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GTx, Inc. (Nasdaq: GTXI), the Men's Health Biotech Company, today announced that ostarine, a first-in-class selective androgen receptor modulator (SARM), met its primary endpoint in a Phase II proof of concept double blind, randomized, placebo controlled clinical trial in 120 subjects (60 elderly men and 60 postmenopausal women). Without a prescribed diet or exercise regimen, all subjects treated with ostarine had a dose dependent increase in total lean body mass (muscle), with the 3 mg cohort achieving an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) after three months of treatment. Treatment with ostarine also resulted in a dose dependent improvement in functional performance measured by a stair climb test, with the 3 mg cohort achieving a clinically significant improvement in both speed (p=0.006) and power (p=0.005). Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported. Ostarine also exhibited tissue selectivity with beneficial effects on lean body mass and performance and with no apparent change in measurements for serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary) compared to placebo.
"These results are exciting," said William J. Evans, Ph.D., Professor of Geriatrics, Physiology, and Nutrition at the Donald W. Reynolds Institute of Aging of the University of Arkansas for Medical Sciences. "Not only was there a change in lean body mass in the clinically significant range, but a significant change in functional performance was also seen. A clear anabolic effect with little to no unwanted androgenic effect was demonstrated, which should be the hallmark of a SARM."
The Phase II clinical trial evaluated four doses of ostarine (0.1 mg, 0.3 mg, 1 mg, and 3 mg) versus placebo for three months in 60 elderly men (average age 66 years) and 60 postmenopausal women (average age 63 years). The trial was conducted in five clinical sites in the United Kingdom and Germany.
A summary of the topline data is as follows:
Primary endpoint: total lean body mass (LBM) measured by dual energy x-ray absorptiometry (DEXA) at baseline compared to three months
-- Among all subjects (n=114), ostarine treatment resulted in a dose dependent increase in total lean body mass, with an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) at the 3 mg dose.
-- Among females (n=56), ostarine treatment resulted in a dose dependent increase in LBM with the 3 mg dose having an increase of 1.7 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.02).
-- Among males (n=5, treatment with a 1 mg dose of ostarine resulted in a LBM increase of 0.7 kg compared to baseline and an increase of 1.2 kg compared to placebo (p=0.03), and treatment with a 3 mg dose of ostarine resulted in an increase of 1.0 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.005).
Secondary endpoints: performance, fat mass, bone mineral density, and bone turnover markers
-- In a stair climb functional performance test that measured speed (time to completion) and power exerted (watts), subjects treated with a 3 mg dose of ostarine demonstrated on average a 15.5% faster time to completion (p=0.006) and exerted on average 25.5% more power (p=0.005) than subjects receiving placebo.
-- Total tissue percent fat decreased compared to placebo in a dose dependent fashion and achieved statistical significance at the 1 mg dose (p=0.02) and 3 mg dose (p=0.006) of ostarine. Total fat mass was lower in subjects receiving either the 3 mg or 1 mg ostarine dose, although not at a statistically significant level (p = 0.08 for both doses). For subjects receiving the 3 mg ostarine dose, total fat on average declined 0.6 kg compared to placebo. The site of fat loss differed among male and female subjects, with males losing fat primarily from the trunk and abdomen, and females losing fat primarily from the thighs and legs.
-- In this short trial, ostarine had no apparent effect on bone mineral density, and bone turnover markers results were mixed. In preclinical in vitro and in vivo models, ostarine demonstrated both anabolic and antiresorptive activity on bone. A longer clinical study is necessary to demonstrate the actual effects of ostarine on bone.
Safety
-- Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported.
-- At the end of three months, no subject had clinically meaningful levels in liver enzyme tests. However, one female discontinued the study per protocol due to elevated liver enzymes which returned to baseline.
-- Ostarine treatment resulted in a dose dependent decrease in both LDL and HDL cholesterol levels, with the average LDL/HDL ratio for all doses tested remaining in the low cardiovascular risk category.
Selectivity
-- Ostarine treatment resulted in no apparent effect on serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary).
"The use of anabolic agents has previously been limited because of concerns over unwanted androgenic and steroidal side effects and oral bioavailability," said Mitchell S. Steiner, MD, CEO of GTx. "Ostarine's safety, tissue selectivity profile, and efficacy results demonstrated in our Phase II clinical trial, combined with oral dosing, distinguish this drug candidate from existing anabolic steroids and testosterone analogues. This opens the door for its potential use in both males and females in a multitude of diseases, including cancer cachexia, end stage renal disease muscle wasting, frailty and osteoporosis."
GTx recently conducted discussions with various divisions of the United States Food & Drug Administration to investigate the required regulatory pathways for several indications under consideration for ostarine's ongoing clinical development. With more clarity regarding the required regulatory pathway and with proof of concept Phase II clinical data, GTx has selected cancer cachexia as the initial acute indication for ostarine development. GTx plans to initiate a Phase IIb ostarine clinical trial for cancer cachexia by the summer of 2007.
Cachexia, or muscle wasting, is a serious result of many cancers, causing selective muscle loss, fatigue, and deteriorating quality of life which adversely impacts response to treatment and overall survival. Cancer cachexia has been identified as one of the two most frequent and devastating problems affecting individuals with advanced malignancies. It has been estimated that a third of the approximately 1.3 million patients diagnosed with cancer in the United States each year will suffer from cancer cachexia. A drug with the ability to increase lean body mass and improve functional performance would address significant unmet needs for the millions of patients living with cancer.
GTx also intends to evaluate the ability of ostarine to treat chronic disease indications including end stage renal disease muscle wasting, frailty and osteoporosis.
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